Research Associate - Analytical R&D

Job Description

Key Responsibilities: Responsible for calibration of all analytical instruments and preparation/maintenance of rest solutions and reagents. Conduct analysis of development batches, stability samples, and comparative dissolution profiles. Lead analytical method development, validation, and preparation of method development reports. Perform drug solubility studies of active pharmaceutical ingredients and execute API & excipient comparability studies. Monitor temperature and humidity in the stability chamber daily while ensuring proper documentation of Analytical R&D activities. Follow GLP, GDP, safety protocols, and compliance guidelines with the Analytical R&D team. Coordinate with cross-functional teams (CFT) for seamless product development within specified timelines. Execute LER-related activities and oversee analytical method development reports for API and FDF. Analyse scale-up and PO batches while managing document issuance, maintenance, and sample submission for laboratory testing. Requirements: MSc with 2-5 years of experience Strong expertise in analytical method development and validation. Experience in comparative dissolution profile analysis and stability studies. Understanding of GLP, GDP, and compliance requirements. Ability to collaborate effectively with CFTs for smooth development activities. Detail-oriented approach to documentation, monitoring, and reporting Show more Show less